A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

The Long-term Safety and Tolerability of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00554385
• Other study ID #: M10-178
• Status: Terminated
• Phase: Phase 2
• First received: November 5, 2007
• Last updated: August 18, 2011
• Start date: November 2007

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 283
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.

• If female, subject must be practicing at least one method of birth control throughout the study.

• If female, the result of a pregnancy test is negative.

• The subject is judged to be in generally good health.

Exclusion Criteria:

• The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.

• The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.

• The subject has a positive urine drug screen for alcohol or drugs of abuse.

• The subject anticipates a move outside the geographic area.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• ABT-089
Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.

Locations

Country	Name	City	State
United States	Site Ref #/Investigator 6836	Austin	Texas
United States	Site Ref #/Investigator 6791	Bellevue	Washington
United States	Site Ref #/Investigator 6812	Boulder	Colorado
United States	Site Ref #/Investigator 8366	Bradenton	Florida
United States	Site Ref #/Investigator 6799	Charleston	South Carolina
United States	Site Ref #/Investigator 6683	Clementon	New Jersey
United States	Site Ref #/Investigator 6682	Eugene	Oregon
United States	Site Ref #/Investigator 6835	Herndon	Virginia
United States	Site Ref #/Investigator 6808	Jacksonville	Florida
United States	Site Ref #/Investigator 6856	Las Vegas	Nevada
United States	Site Ref #/Investigator 8383	Libertyville	Illinois
United States	Site Ref #/Investigator 6800	Little Rock	Arkansas
United States	Site Ref #/Investigator 7955	Memphis	Tennessee
United States	Site Ref #/Investigator 6838	Middleton	Wisconsin
United States	Site Ref #/Investigator 6802	Northbrook	Illinois
United States	Site Ref #/Investigator 8297	Oklahoma City	Oklahoma
United States	Site Ref #/Investigator 6902	Omaha	Nebraska
United States	Site Ref #/Investigator 6827	Orlando	Florida
United States	Site Ref #/Investigator 6824	Overland Park	Kansas
United States	Site Ref #/Investigator 6811	Portland	Oregon
United States	Site Ref #/Investigator 8701	Portland	Oregon
United States	Site Ref #/Investigator 6681	Salem	Oregon
United States	Site Ref #/Investigator 8428	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD-RS-IV (HV)		Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12	No
Primary	CGI-ADHD-S		Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12	No